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“This case is unworthy of certiorari because it concerns the application of settled law to particular facts,” according to Myriad Genetics Inc.'s brief in opposition to the cert petition challenging its patents on isolated DNA (Association for Molecular Pathology v. Myriad Genetics Inc., U.S., No. 12-398, opposition brief filed 10/31/12).

The petition appeals a 2-1 decision by the U.S. Court of Appeals for the Federal Circuit that isolated DNA claims of patents exclusively licensed to Myriad are patent eligible under 35 U.S.C. §101.

Myriad devoted much of the brief to disputing the phrasing of the first question presented--“Are human genes patentable?”--by the organizations behind the challenge, the American Civil Liberties Union and the Public Patent Foundation.

The case is not about patenting “native” human genes, Myriad said. “The challenged composition claims are instead narrowly drawn to specific, defined DNA molecules, isolated by human scientists in laboratories, that do not naturally occur.”

The patent owner thus accused the petitioners of “a misunderstanding of basic scientific principles, well-established case law, and the nature of the composition claims at issue.”

Myriad also cautioned that the court risked disrupting settled expectations of the biotechnology community, saying that the court “should take into account the consequences of a legal rule that would apply far beyond the realm of human DNA.”

Challenge Began in 2009.

The case arose from a 2009 declaratory judgment challenge filed by the ACLU and PubPat, on behalf of the Association of Molecular Pathology and other medical associations, individuals involved in medical research, breast cancer counselors, and women diagnosed with or seeking diagnosis for cancer (78 PTCJ 64, 5/15/09).

They argued that particular claims in patents (5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,170,001, 5,753,441; and 6,033,857) on isolated DNA, cDNA, and methods related to the BRCA1 and BRCA2 genes associated with hereditary breast and ovarian cancer were ineligible for patenting under 35 U.S.C. §101.

In its first decision, the Federal Circuit agreed that only one of the method claims and all the claims to cDNA are patent eligible, but the court was divided as to claims to isolated DNA. Association for Molecular Pathology v. U.S. Patent and Trademark Office, 653 F.3d 1329, 99 USPQ2d 1398 (Fed. Cir. 2011) (82 PTCJ 449, 8/5/11).

On remand, however, the appeals court panel came to the same conclusions, with all three judges writing essentially the same opinions that they had penned the first time. 689 F.3d 1303, 103 USPQ2d 1681 (Fed. Cir. 2012) (84 PTCJ 696, 8/24/12).

On Sept. 25, the challengers once again filed a petition for cert (84 PTCJ 901, 9/28/12).

“[T]he Court has not addressed the patent eligibility of compositions of matter for over thirty years,” according to the petition. A revisit in light of gene patenting is “of paramount importance to the future of patent law, the advancement of medical science, and the health of patients,” the ACLU argued.

Myriad Contests the Question Presented.

“Of course, the genetic material naturally existing in every human being is not an 'invention,' i.e., it is not the product of human ingenuity,” according to the brief. “But this case does not involve claims to such 'native' human genes.” The brief continued with more than four pages dedicated to countering the petitioners' “misstatements” on five separate grounds.

As Chakrabarty held, a composition created with “human ingenuity” and having a “distinctive name, character [and] use” from what exists in nature is what separates “a hitherto unknown natural phenomenon,” ineligible for patent protection, from “a nonnaturally occurring manufacture or composition of matter,” which is patent-eligible. Id. at 309-10.

In fact, Myriad claimed that the petitioners agree with the Chakrabartytest and that the petition is based on an improper use of that test by the Federal Circuit. The case is not worthy for the high court's consideration, Myriad said, “because an allegation of 'misapplication of a properly stated rule of law' is rarely a legitimate basis for certiorari review,” quoting Sup. Ct. R. 10.

Repeatedly, though, the brief returned to Chakrabarty. “[T]he particular claimed molecules are 'product of human ingenuity' that, because of their definition and isolation by human inventors, have been given new characteristics from the 'native' gene embedded in the genome, and substantial new utilities as diagnostic tools.”

No Preemption of Broader Products, Services.

Myriad also sought to defuse arguments related to preemption, that the patents prevent developments in a wide array of genome sequencing efforts.

“The patents impede new advances in genetic testing that can efficiently sequence the many genes now associated with breast and ovarian cancer, or indeed the entire human genome,” according to the ACLU petition.

Myriad disclaimed the broad scope of patent protection. “Such sequencing, which does not require isolation of a BRCA-specific DNA molecule but instead randomly selects genetic material to sequence a patient's entire genetic makeup, is not covered by the challenged claims,” according to the brief.

Later in the brief, Myriad further limited its list of potential infringing technologies:

These claims do not preempt or preclude other technologies that have been developed and are currently being used to study the human genome and identify genetic mutations to assess a patient's cancer predisposition--e.g., gene expression profiles, whole-genome sequencing, untargeted single-molecule sequencing, and protein-truncation testing. … These technologies “sequence” DNA without the need for “isolation.”

One Method Claim at Issue.

The second question the ACLU presented to the court was: “Did the … Federal Circuit err in upholding a method claim by Myriad … that is irreconcilable with the Supreme Court's ruling in [Mayo v. Prometheus]?”

The first time around, the appeals court held that Claim 20 of the '282 patent, which covers a “method of screening potential cancer therapeutics” with a step of growing host cells under certain conditions before “determining” whether the rate of growth is indicative of a cancer therapeutic, passed muster under Section 101.

The Mayo decision was confined to method claims at issue there, and the court held that the “inventive concept” of the claims was an ineligible “law of nature.” The high court's remand potentially signalled reconsideration of Claim 20.

However, the Federal Circuit said on remand, “we once again, even in light of Mayo, arrive at the same conclusion of patent-eligibility because at the heart of claim 20 is a transformed cell, which is made by man, in contrast to a natural material.”

The ACLU brief cited parallels between the claim and those found patent ineligible by the Mayo court, but the Myriad opposition brief distinguished the two:

Claim 20, by contrast, “does significantly more” than simply describe natural laws. Indeed, the claim starts not with a “natural law” (as in Mayo), but with a new and useful product of human ingenuity--“a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer”--and applies additional steps to that transformed cell so that a new, useful, and inventive method of determining the efficacy of a cancer therapeutic was made available to the public.

Standing Issue Must Be Reconsidered.

Finally, the ACLU asked the court to consider the question: “Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and the Supreme Court's decision in MedImmune Inc. v. Genentech Inc., 549 U.S. 118, 81 USPQ2d 1225 (2007) (73 PTCJ 242, 1/12/07), that petitioners who have been indisputably deterred by Myriad's “active enforcement” of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?”

Of the 20 plaintiffs listed on the original complaint, the Federal Circuit held that only one--Harry Ostrer, a researcher at New York University School of Medicine who was allegedly interested in sequencing the BRCA1 and BRCA2 genes--met the requirements for declaratory judgment standing. In the cert petition, the ACLU argued in favor of the other 19.

In its opposition brief, Myriad countered not only the case for the other 19, but suggested that the court must reconsider whether Ostrer still had standing, based on his move to a different lab just before the Federal Circuit's decision.

The appeals court denied Myriad's “suggestion of mootness” as a result of this move when the court ruled the second time (84 PTCJ 256, 6/15/12). However, Myriad insisted, “This Court would have to consider this issue to assure itself of Article III jurisdiction before reaching any of the § 101 issues.”

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